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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL 200 S/C PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL 200 S/C PISTON SYRINGE Back to Search Results
Model Number 309657
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the syringe 3ml ll 200 s/c experienced difficulty connecting the syringe to the mating component, resulting in leakage. The following information was provided by the initial reporter: i did notice in my last injection that there was no medicine leaking into the 1/4 gap. But i did try to twist the needle particularly hard to minimize the gap, but it still wasn't eliminated. It does still mean, if the needle doesn't seat firmly into the syringe that the measurement of the medicine is incorrect. The needle only twists into the syringe about 3/4 of the way creating a small gap. Medicine gets trapped in this gap and does not go into me.
 
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Brand NameSYRINGE 3ML LL 200 S/C
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12573538
MDR Text Key274742589
Report Number1213809-2021-00689
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309657
Device Catalogue Number309657
Device Lot Number0195485
Was Device Available for Evaluation? No
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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